Trial Outcomes & Findings for CRT Implant Strategy Using the Longest Electrical Delay for Non-left Bundle Branch Block Patients (NCT NCT01983293)

NCT ID: NCT01983293

Last Updated: 2019-03-13

Results Overview

Evaluate the Clinical Composite Score (CCS) at 12 months in NLBBB patients using a standard of care vs. latest electrical delay (QLV) implant strategy. The CCS has 4 components: New York Heart Association (NYHA) functional classification, Patient Global Assessment (PGA), heart failure (HF) events, cardiovascular death. NYHA Class ranges from Class I (least severe) to Class IV (most severe); possible PGA responses are "markedly worse", "moderately worse", "slightly worse", "no change", "slightly better", "moderately better, "markedly better". CCS components were used to classify or score subjects as "IMPROVED" (at least one-class improvement in NYHA Class or improvement by PGA "moderately" or "markedly" better AND no HF events AND no cardiovascular death), or "WORSENED" (worsening in NYHA Class OR worsening by PGA "moderately" or "markedly" worse OR presence of HF events OR Cardiovascular death, or "UNCHANGED" (neither "improved" or "worsened"). Note CCS is not a numeric score.

Recruitment status

COMPLETED

Study phase

Target enrollment

248 participants

Primary outcome timeframe

12 months

Results posted on

2019-03-13

Participant Flow

The study enrolled 248 subjects, with 247 having an attempted implant. Of the 247 subjects with an attempted implant, three subjects were excluded from analysis based on having a LBBB morphology and two excluded based on QRS duration \<120 ms.

Participant milestones

Participant milestones
Measure	QLV Study Arm The QLV study arm includes those patients randomized to receive the placement of the left ventricular CRT lead based on the site of latest electrical delay within the left ventricle.	Standard of Care Study Arm The Standard of Care study arm includes those patients randomized to receive the placement of the left ventricular CRT lead based on the investigator's standard of care implant approach.
Overall Study STARTED	161	81
Overall Study COMPLETED	128	62
Overall Study NOT COMPLETED	33	19

Reasons for withdrawal

Reasons for withdrawal
Measure	QLV Study Arm The QLV study arm includes those patients randomized to receive the placement of the left ventricular CRT lead based on the site of latest electrical delay within the left ventricle.	Standard of Care Study Arm The Standard of Care study arm includes those patients randomized to receive the placement of the left ventricular CRT lead based on the investigator's standard of care implant approach.
Overall Study Withdrawal by Subject	29	15
Overall Study Missing 12-month visit	3	3
Overall Study Missing NYHA/Patient Global Assessment	1	1

Baseline Characteristics

The study enrolled 248 subjects, 247 having an attempted implant. Three subjects presented with a LBBB morphology and two with QRS durations \<120 ms.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	QLV Study Arm n=161 Participants The QLV study arm includes those patients randomized to receive the placement of the left ventricular CRT lead based on the site of latest electrical delay within the left ventricle.	Standard of Care Study Arm n=81 Participants The Standard of Care study arm includes those patients randomized to receive the placement of the left ventricular CRT lead based on the investigator's standard of care implant approach.	Total n=242 Participants Total of all reporting groups
Age, Continuous	65.7 years STANDARD_DEVIATION 12.1 • n=5 Participants • The study enrolled 248 subjects, 247 having an attempted implant. Three subjects presented with a LBBB morphology and two with QRS durations \<120 ms.	64.1 years STANDARD_DEVIATION 13.3 • n=7 Participants • The study enrolled 248 subjects, 247 having an attempted implant. Three subjects presented with a LBBB morphology and two with QRS durations \<120 ms.	65.2 years STANDARD_DEVIATION 12.5 • n=5 Participants • The study enrolled 248 subjects, 247 having an attempted implant. Three subjects presented with a LBBB morphology and two with QRS durations \<120 ms.
Sex: Female, Male Female	27 Participants n=5 Participants • The study enrolled 248 subjects, 247 having an attempted implant. Three subjects presented with a LBBB morphology and two with QRS durations \<120 ms.	21 Participants n=7 Participants • The study enrolled 248 subjects, 247 having an attempted implant. Three subjects presented with a LBBB morphology and two with QRS durations \<120 ms.	48 Participants n=5 Participants • The study enrolled 248 subjects, 247 having an attempted implant. Three subjects presented with a LBBB morphology and two with QRS durations \<120 ms.
Sex: Female, Male Male	134 Participants n=5 Participants • The study enrolled 248 subjects, 247 having an attempted implant. Three subjects presented with a LBBB morphology and two with QRS durations \<120 ms.	60 Participants n=7 Participants • The study enrolled 248 subjects, 247 having an attempted implant. Three subjects presented with a LBBB morphology and two with QRS durations \<120 ms.	194 Participants n=5 Participants • The study enrolled 248 subjects, 247 having an attempted implant. Three subjects presented with a LBBB morphology and two with QRS durations \<120 ms.
Ethnicity (NIH/OMB) Hispanic or Latino	12 Participants n=5 Participants	5 Participants n=7 Participants	17 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	147 Participants n=5 Participants	75 Participants n=7 Participants	222 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
NYHA Classification NYHA II	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
NYHA Classification NYHA III	157 Participants n=5 Participants	71 Participants n=7 Participants	228 Participants n=5 Participants
NYHA Classification NYHA IV	4 Participants n=5 Participants	9 Participants n=7 Participants	13 Participants n=5 Participants
Type of Cardiomyopathy Ischemic	100 Participants n=5 Participants	45 Participants n=7 Participants	145 Participants n=5 Participants
Type of Cardiomyopathy Non-ischemic	55 Participants n=5 Participants	33 Participants n=7 Participants	88 Participants n=5 Participants
Type of Cardiomyopathy None	6 Participants n=5 Participants	3 Participants n=7 Participants	9 Participants n=5 Participants
Types of QRS Morphology Intraventricular Conduction Delay	55 Participants n=5 Participants	33 Participants n=7 Participants	88 Participants n=5 Participants
Types of QRS Morphology Right Bundle Branch Block	86 Participants n=5 Participants	36 Participants n=7 Participants	122 Participants n=5 Participants
Types of QRS Morphology Right Bundle Branch/Left Anterior Fascicular Block	15 Participants n=5 Participants	9 Participants n=7 Participants	24 Participants n=5 Participants
Types of QRS Morphology Right Bundle/Left Posterior Fascicular Block	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Types of QRS Morphology Other	3 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants
QRS Duration 120-149 msec	75 Participants n=5 Participants	33 Participants n=7 Participants	108 Participants n=5 Participants
QRS Duration >= 150 msec	86 Participants n=5 Participants	48 Participants n=7 Participants	134 Participants n=5 Participants

PRIMARY outcome

Timeframe: 12 months

Population: Of the 242 subjects enrolled, 44 withdrew for reasons other than cardiac death, six had a missing 12-month visit for reasons other than a heart failure event and two had missing Patient Global Assessments or NYHA classification assessments. As a result, the primary endpoint analysis included 190 enrolled subjects (128 QLV arm; 62 control arm).

Outcome measures

Outcome measures
Measure	QLV Study Arm n=128 Participants The QLV study arm includes those patients randomized to receive the placement of the left ventricular CRT lead based on the site of latest electrical delay within the left ventricle.	Standard of Care Study Arm n=62 Participants The Standard of Care study arm includes those patients randomized to receive the placement of the left ventricular CRT lead based on the investigator's standard of care implant approach.
Number of Patients With Improved Clinical Composite Score	86 Participants	45 Participants

Adverse Events

Standard of Care

Serious events: 4 serious events

Other events: 14 other events

Deaths: 4 deaths

QLV Based Lead Implant

Serious events: 8 serious events

Other events: 31 other events

Deaths: 9 deaths

Serious adverse events

Serious adverse events
Measure	Standard of Care n=62 participants at risk In the control arm, investigators implanted the LV lead without the use of QLV measurements and instead used standard practices to identify the most suitable LV lead location	QLV Based Lead Implant n=128 participants at risk In the QLV arm, the implanting physician assessed the QLV in at least two main branches of the coronary sinus for LV lead placement
Injury, poisoning and procedural complications Bleeding/Hematoma	1.6% 1/62 • Number of events 1 • Adverse Events were collected over a time period of 1 year from enrollment Adverse events are any unfavorable clinical event which impacts, or has the potential to impact the health or safety of a patient caused by or associated with a study device or intervention. Adverse events are classified as complication or observations. Complications: Adverse events that require invasive intervention. Observations: Adverse events that can be managed without invasive intervention.	0.00% 0/128 • Adverse Events were collected over a time period of 1 year from enrollment Adverse events are any unfavorable clinical event which impacts, or has the potential to impact the health or safety of a patient caused by or associated with a study device or intervention. Adverse events are classified as complication or observations. Complications: Adverse events that require invasive intervention. Observations: Adverse events that can be managed without invasive intervention.
Injury, poisoning and procedural complications Cardiac Tamponade	1.6% 1/62 • Number of events 1 • Adverse Events were collected over a time period of 1 year from enrollment Adverse events are any unfavorable clinical event which impacts, or has the potential to impact the health or safety of a patient caused by or associated with a study device or intervention. Adverse events are classified as complication or observations. Complications: Adverse events that require invasive intervention. Observations: Adverse events that can be managed without invasive intervention.	0.00% 0/128 • Adverse Events were collected over a time period of 1 year from enrollment Adverse events are any unfavorable clinical event which impacts, or has the potential to impact the health or safety of a patient caused by or associated with a study device or intervention. Adverse events are classified as complication or observations. Complications: Adverse events that require invasive intervention. Observations: Adverse events that can be managed without invasive intervention.
Injury, poisoning and procedural complications Lead Dislodgement Or Migration	1.6% 1/62 • Number of events 1 • Adverse Events were collected over a time period of 1 year from enrollment Adverse events are any unfavorable clinical event which impacts, or has the potential to impact the health or safety of a patient caused by or associated with a study device or intervention. Adverse events are classified as complication or observations. Complications: Adverse events that require invasive intervention. Observations: Adverse events that can be managed without invasive intervention.	3.1% 4/128 • Number of events 4 • Adverse Events were collected over a time period of 1 year from enrollment Adverse events are any unfavorable clinical event which impacts, or has the potential to impact the health or safety of a patient caused by or associated with a study device or intervention. Adverse events are classified as complication or observations. Complications: Adverse events that require invasive intervention. Observations: Adverse events that can be managed without invasive intervention.
Injury, poisoning and procedural complications Pneumothorax	1.6% 1/62 • Number of events 1 • Adverse Events were collected over a time period of 1 year from enrollment Adverse events are any unfavorable clinical event which impacts, or has the potential to impact the health or safety of a patient caused by or associated with a study device or intervention. Adverse events are classified as complication or observations. Complications: Adverse events that require invasive intervention. Observations: Adverse events that can be managed without invasive intervention.	0.00% 0/128 • Adverse Events were collected over a time period of 1 year from enrollment Adverse events are any unfavorable clinical event which impacts, or has the potential to impact the health or safety of a patient caused by or associated with a study device or intervention. Adverse events are classified as complication or observations. Complications: Adverse events that require invasive intervention. Observations: Adverse events that can be managed without invasive intervention.
Injury, poisoning and procedural complications Atrial Or Ventricular Arrhythmia	0.00% 0/62 • Adverse Events were collected over a time period of 1 year from enrollment Adverse events are any unfavorable clinical event which impacts, or has the potential to impact the health or safety of a patient caused by or associated with a study device or intervention. Adverse events are classified as complication or observations. Complications: Adverse events that require invasive intervention. Observations: Adverse events that can be managed without invasive intervention.	0.78% 1/128 • Number of events 1 • Adverse Events were collected over a time period of 1 year from enrollment Adverse events are any unfavorable clinical event which impacts, or has the potential to impact the health or safety of a patient caused by or associated with a study device or intervention. Adverse events are classified as complication or observations. Complications: Adverse events that require invasive intervention. Observations: Adverse events that can be managed without invasive intervention.
Injury, poisoning and procedural complications Cardiac Perforation	0.00% 0/62 • Adverse Events were collected over a time period of 1 year from enrollment Adverse events are any unfavorable clinical event which impacts, or has the potential to impact the health or safety of a patient caused by or associated with a study device or intervention. Adverse events are classified as complication or observations. Complications: Adverse events that require invasive intervention. Observations: Adverse events that can be managed without invasive intervention.	0.78% 1/128 • Number of events 1 • Adverse Events were collected over a time period of 1 year from enrollment Adverse events are any unfavorable clinical event which impacts, or has the potential to impact the health or safety of a patient caused by or associated with a study device or intervention. Adverse events are classified as complication or observations. Complications: Adverse events that require invasive intervention. Observations: Adverse events that can be managed without invasive intervention.
Injury, poisoning and procedural complications Coronary Sinus Dissection	0.00% 0/62 • Adverse Events were collected over a time period of 1 year from enrollment Adverse events are any unfavorable clinical event which impacts, or has the potential to impact the health or safety of a patient caused by or associated with a study device or intervention. Adverse events are classified as complication or observations. Complications: Adverse events that require invasive intervention. Observations: Adverse events that can be managed without invasive intervention.	0.78% 1/128 • Number of events 1 • Adverse Events were collected over a time period of 1 year from enrollment Adverse events are any unfavorable clinical event which impacts, or has the potential to impact the health or safety of a patient caused by or associated with a study device or intervention. Adverse events are classified as complication or observations. Complications: Adverse events that require invasive intervention. Observations: Adverse events that can be managed without invasive intervention.
Product Issues Lead Fracture	0.00% 0/62 • Adverse Events were collected over a time period of 1 year from enrollment Adverse events are any unfavorable clinical event which impacts, or has the potential to impact the health or safety of a patient caused by or associated with a study device or intervention. Adverse events are classified as complication or observations. Complications: Adverse events that require invasive intervention. Observations: Adverse events that can be managed without invasive intervention.	0.78% 1/128 • Number of events 1 • Adverse Events were collected over a time period of 1 year from enrollment Adverse events are any unfavorable clinical event which impacts, or has the potential to impact the health or safety of a patient caused by or associated with a study device or intervention. Adverse events are classified as complication or observations. Complications: Adverse events that require invasive intervention. Observations: Adverse events that can be managed without invasive intervention.
Cardiac disorders Therapy For Non-Ventricular Rhythm	0.00% 0/62 • Adverse Events were collected over a time period of 1 year from enrollment Adverse events are any unfavorable clinical event which impacts, or has the potential to impact the health or safety of a patient caused by or associated with a study device or intervention. Adverse events are classified as complication or observations. Complications: Adverse events that require invasive intervention. Observations: Adverse events that can be managed without invasive intervention.	0.78% 1/128 • Number of events 1 • Adverse Events were collected over a time period of 1 year from enrollment Adverse events are any unfavorable clinical event which impacts, or has the potential to impact the health or safety of a patient caused by or associated with a study device or intervention. Adverse events are classified as complication or observations. Complications: Adverse events that require invasive intervention. Observations: Adverse events that can be managed without invasive intervention.

Other adverse events

Additional Information

Clay Cohorn

Abbott

Phone: 1 972 309 8087

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place